trial-based economic evaluation of a mobile health intervention for individuals with chronic non-specific low back pain

Conditions: Low Back Pain

Summary: the aim of this trial is to assess the effectiveness and cost-effectiveness of a supervised and more personalised mhealth intervention compared with conventional exercise therapy in people with chronic non-specific low back pain.

background: chronic non-specific low back pain (cnlbp) is a prevalent and costly condition that encourages research into self-management strategies. mobile health (mhealth) applications are promising interventions, but current evidence on their effectiveness is still conflicting. the aim is to investigate the (cost-)effectiveness of a supervised and personalized mhealth intervention, compared with conventional exercise therapy in individuals with cnlbp. methods: a multicentre trial-based economic evaluation was designed to compare a mhealth intervention with conventional exercise. participants will be recruited from two physical therapy rehabilitation clinics located within the participating centres. adults aged between 18 and 59 years and with self-reported lbp \>12 weeks will be included. following the collection of baseline data, participants will be randomly assigned to one of two groups using a permuted block randomization: 1) mhealth; 2) conventional exercise delivered through a booklet. outcome assessments will be conducted following randomisation at five distinct time points, resulting in a total follow-up period of 12 months. the primary clinical outcome is disability (roland-morris disability questionnaire), while secondary outcomes include pain (nrs), utility (eq5d5l), fears and beliefs (fabq), self-efficacy (pseq), and global perceived effect. a sample size of 146 participants was estimated (73 allocated to each group) in order to detect a 2-point between-groups difference on disability. a cost-effectiveness study will be conducted alongside the trial, comparing the two interventions in terms of costs and clinical outcomes. discussion: while mhealth applications show promise as interventions for people with lbp, there is still a gap regarding the type of delivery and personalisation strategies. this study investigates whether the implementation of stratified and tailored care within a mobile application, based on patient-reported outcome measures and supervised by a physiotherapist, is (cost)effective.

Eligibility criteria:
inclusion criteria: * adults aged between 18 and 59 years; * self-reported low back pain for more than 12 consecutive weeks prior to the study, with pain intensity ≥4 in the numerical rating scale (nrs); * not having participated in physiotherapy sessions for treatment of low back pain for at least 6 months prior to the start of the study; * having a smartphone with internet access; * self-management activation classified as level 2 or higher (i.e., classifications of low, medium and high knowledge about self-management), according to the patient activation measure (pam) questionnaire. exclusion criteria: * history of spinal trauma or fracture; * diagnosis of spinal osteoarthritis, fibromyalgia, or rheumatic diseases; 3) referred pain (from viscera, appendicitis, abdominal and pelvic pain); * previous spinal surgery; * presence of red flags, signs and/or symptoms of neurological impairment and/or pain radiating below the knee; * pregnancy.

Keywords: back pain mobile health economic evaluation exercise therapy self-management